An interventional study of TENS and t-NMES in Stroke, sponsored by MetroHealth Medical Center. Completed. Open to participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Treatment
Examination of the effects of short-term use of TENS and t-NMES on passive pain-free ROM of the painful post-stroke shoulder. Treatments are compared with no stimulation.
Single cohort, cross-over study. Subjects undergo passive pain-free ROM of the painful post-stroke shoulder under 3 stimulation conditions. The stimulation was delivered by a trained occupational therapist under three conditions: 10 seconds of TENS, 10 seconds of t-NMES, and 10 seconds of no stimulation. Each subject was exposed to each of the three stimulation conditions three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation. This protocol is repeated for each of the two passive movements tested, shoulder abduction and shoulder external rotation.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →MetroHealth Medical Center is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
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Exclusion Criteria:
TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to each stimulation 3 times for each shoulder ROM.
Device: TENS · Device: t-NMES · Other: No stimulation
Electrical Stimulation
Also known as: Transcutaneous Electrical Nerve Stimulation
Electrical Stimulation
Also known as: transcutaneous-Neuromuscular Electrical Stimulation
No stimulation
Passive Range of Motion of Shoulder in Shoulder External Rotation
passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer
Time frame: 10 seconds
Passive Range of Motion of Shoulder in Shoulder Abduction
passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer
Time frame: 10 seconds
| Milestone | Hemiplegic Shoulder Pain |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer
| degrees | TENS | t-NMES | No Stimulation |
|---|---|---|---|
| Passive Range of Motion of Shoulder in Shoulder External Rotation | 66.9 (46.9 to 86.8) | 67.4 (49.4 to 85.4) | 69.1 (49.6 to 88.7) |
passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer
| degrees | TENS | t-NMES | No Stimulation |
|---|---|---|---|
| Passive Range of Motion of Shoulder in Shoulder Abduction | 87.8 (70.0 to 105.7) | 87.5 (69.8 to 105.1) | 89.6 (73.9 to 105.4) |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hemiplegic Shoulder Pain | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
All participants underwent all interventions.
| Age, Continuous(years) | TENS/t-NMES/No Stimulation |
|---|---|
| Mean | 59.1 ± 11.3 |
| Sex: Female, Male(Participants) | TENS/t-NMES/No Stimulation |
|---|---|
| Female | 6 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | TENS/t-NMES/No Stimulation |
|---|
| Months since stroke(months) | TENS/t-NMES/No Stimulation |
|---|---|
| Mean | 46.8 ± 42.1 |
| Right sided stroke(Participants) | TENS/t-NMES/No Stimulation |
|---|---|
| Count of participants | 6 |
| Worst shoulder pain in the last week (0 min-10 max)(units on a scale) | TENS/t-NMES/No Stimulation |
|---|---|
| Mean | 7.8 ± 2.5 |
No study locations are listed for this record.
Plan to share: No
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